Drug: Clarinex-D 24hr

CLARINEX-D 24 HOUR Extended Release Tablets are light blue oval-shaped tablets containing 5 mg desloratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate USP in the tablet core for extended release. The inactive ingredients contained in CLARINEX-D 24 HOUR Extended Release Tablets are hypromellose USP, ethylcellulose NF, dibasic calcium phosphate dihydrate USP, magnesium stearate NF, povidone USP, silicone dioxide NF, talc USP, polyacrylate dispersion, polyethylene glycol NF, simethicone USP, Blue Lake Blend 50726 (FD&C Blue No. 2 Lake, titanium dioxide USP and edetate disodium USP), and ink (Opacode® S-1-17746 or Opacode® S-1-4159). Desloratadine, 1 of the 2 active ingredients of CLARINEX-D 24 HOUR Extended Release Tablets, is a white to off-white powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. It has an empirical formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2- b]pyridine and has the following structure: Pseudoephedrine sulfate, the other active ingredient of CLARINEX-D 24 HOUR Extended Release Tablets, is the synthetic salt of one of the naturally occurring dextrorotatory diastereomers of ephedrine and is classified as an indirect sympathomimetic amine. Pseudoephedrine sulfate is a colorless hygroscopic crystal or white, hygroscopic crystalline powder, practically odorless, with a bitter taste. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in ether. The empirical formula for pseudoephedrine sulfate is (C10H15NO)2 • H2SO4; the chemical name is benzenemethanol, α-[1-(methylamino) ethyl]-,[S-(R*,R*)]-, sulfate (2:1)(salt); and the chemical structure is:

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The following adverse reactions are discussed in greater detail in other sections of the label:
  • Cardiovascular and Central Nervous System effects [see WARNINGS AND PRECAUTIONS]
  • Increased intraocular pressure [see WARNINGS AND PRECAUTIONS]
  • Urinary retention in patients with prostatic hypertrophy [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data described below are from 2 clinical trials with CLARINEX-D 24 HOUR Extended Release Tablets that included 2852 patients, of which 708 patients received CLARINEX-D 24 HOUR Extended Release Tablets daily for up to 15 days. The majority of patients were between 18 and < 65 years of age with a mean age of 34.3 years and were predominantly women (63%). Patient ethnicity was 79 % Caucasian, 10% Black, 8 % Hispanic and 3% Asian/other ethnicity. The percentage of subjects receiving CLARINEX-D 24 HOUR Extended Release Tablets, and who discontinued from the clinical trials because of an adverse event was 3.4%. Adverse reactions that were reported by ≥ 2% of subjects receiving CLARINEX-D 24 HOUR Extended Release Tablets are shown in Table 1. Table 1: Incidence of Adverse Reactions Reported by ≥ 2% of Subjects Receiving CLARINEX-D 24 HOUR Extended Release Tablets
Adverse Reaction CLARINEX-D 24 HOUR
(N=708) Desloratadine 5 mg
(N=712) Pseudoephedrine 240 mg
(N=719) Gastrointestinal Disorders Mouth Dry 8% 2% 11% Nausea 2% 1% 3% Anorexia 2% 0% 2% General Disorders and Administration Site Conditions Fatigue 3% 3% 2% Nervous System Disorders Headache 6% 5% 7% Somnolence 3% 2% 3% Dizziness 2% 1% 2% Psychomotor hyperactivity 2% 0% 2% Psychiatric Disorders Insomnia 5% 1% 8% Nervousness 2% 1% 1% Respiratory, Thoracic and Mediastinal Disorders Pharyngitis 3% 2% 3% There were no relevant differences in adverse reactions for subgroups of patients as defined by gender, age, or race. Post-Marketing Experience In addition to the adverse reactions reported during clinical trials and listed above, adverse events have been identified during post approval use of CLARINEX-D 24 HOUR Extended Release Tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse events identified from post-marketing surveillance on the use of CLARINEX-D 24 HOUR Extended Release Tablets include palpitations, pruritus and urticaria. In addition to these events, the following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product: headache, somnolence, dizziness, tachycardia, and rarely hypersensitivity reactions (such as rash, edema, dyspnea, and anaphylaxis), movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin and very rarely, hepatitis. Read the Clarinex-D 24hr (desloratadine and pseudoephedrine sulfate) Side Effects Center for a complete guide to possible side effectsLearn More »

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Administer CLARINEX-D 24 HOUR Extended Release Tablet by the oral route only. Do not break, chew or crush the tablet. Swallow the tablet whole. Adults And Adolescents 12 Years Of Age And Over The recommended dose of CLARINEX-D 24 HOUR Extended Release Tablets is 1 tablet once daily, administered with or without a meal. Higher doses or increased dosing frequency of CLARINEX-D 24 HOUR Extended Release Tablets have not demonstrated increased effectiveness. Do not exceed the recommended dose as desloratadine and pseudoephedrine, the active components of CLARINEX-D 24 HOUR Extended Release Tablets have been associated with adverse effects at higher doses [see OVERDOSAGE].

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No specific interaction studies have been conducted with CLARINEX-D 24 HOUR Extended Release Tablets. Monoamine Oxidase Inhibitors CLARINEX-D 24 HOUR Extended Release Tablets should not be used in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment because the action of pseudoephedrine a component of CLARINEX-D 24 HOUR Extended Release tablets on the vascular system may be potentiated by these agents [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]. Beta-Adrenergic Blocking Agents The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, and reserpine, may be reduced by sympathomimetics such as pseudoephedrine. Exercise caution when using CLARINEX-D 24 HOUR Extended Release Tablets with these agents. Digitalis Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis. Exercise caution when using CLARINEX-D 24 HOUR Extended Release Tablets with these agents. Inhibitors Of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine [see CLINICAL PHARMACOLOGY]. Fluoxetine In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine [see CLINICAL PHARMACOLOGY]. Cimetidine In controlled clinical studies co-administration of desloratadine with cimetidine a histamine H2-receptor antagonist resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine [see CLINICAL PHARMACOLOGY]. Drug Abuse And Dependence There is no information to indicate that abuse or dependency occurs with CLARINEX or CLARINEX-D 24 HOUR Extended Release Tablets. Read the Clarinex-D 24hr Drug Interactions Center for a complete guide to possible interactions Learn More »

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Seasonal Allergic Rhinitis CLARINEX-D® 24 HOUR Extended Release Tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. CLARINEX-D 24 HOUR Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired [see CLINICAL PHARMACOLOGY].

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CLARINEX-D 24 HOUR Extended Release Tablets are contraindicated in:
  • Patients with hypersensitivity to any of its ingredients, or to loratadine [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]
  • Patients with narrow angle glaucoma
  • Patients with urinary retention
  • Patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment [see DRUG INTERACTIONS].
  • Patients with severe hypertension or severe coronary artery disease.
Last reviewed on RxList: 5/5/2014
This monograph has been modified to include the generic and brand name in many instances.

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In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis. Desloratadine Information regarding acute overdosage with desloratadine is limited to experience from postmarketing adverse event reports and from clinical trials conducted during the development of the CLARINEX product. In the reported cases of overdose, there were no significant adverse events that were attributed to desloratadine. In a dose ranging trial, at doses of 10 mg and 20 mg/day somnolence was reported. In another study, no clinically relevant adverse events were reported in normal male and female volunteers who were given single daily doses of CLARINEX 45 mg for 10 days [see CLINICAL PHARMACOLOGY]. Lethality occurred in rats at oral doses of 250 mg/kg or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose). The oral median lethal dose in mice was 353 mg/kg (estimated desloratadine exposure was approximately 290 times the human daily oral dose on an mg/m² basis). No deaths occurred at oral doses up to 250 mg/kg in monkeys (estimated desloratadine exposures were approximately 810 times the human daily oral dose on an mg/m² basis). Sympathomimetics In large doses, sympathomimetics such as pseudoephedrine may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscle weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure.

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Dosage Forms And Strengths CLARINEX-D 24 HOUR Extended Release Tablets are oval-shaped, light blue coated tablets with “D 24” branded in black on one side. Each tablet contains 5 mg desloratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate USP in an extended release core. Storage And Handling CLARINEX-D 24 HOUR Extended Release Tablets are oval-shaped, light blue coated tablets with “D24” branded in black on one side containing 5 mg desloratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate USP in an extended release core. CLARINEX-D 24 HOUR Extended Release Tablets are supplied in high-density polyethylene bottles of 100 (NDC 0085-1317-01). Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Heat Sensitive. Avoid exposure at or above 30°C (86°F). Protect from excessive moisture. Protect from light. Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: March 2014 Last reviewed on RxList: 5/5/2014
This monograph has been modified to include the generic and brand name in many instances.

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Cardiovascular And Central Nervous System Effects The pseudoephedrine sulfate contained in CLARINEX-D 24 HOUR Extended Release Tablets, like other sympathomimetic amines, can produce cardiovascular and central nervous system (CNS) effects in some patients such as insomnia, dizziness, weakness, tremor, or arrhythmias. In addition, central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension has been reported. Therefore, CLARINEX-D 24 HOUR Extended Release Tablets should be used with caution in patients with cardiovascular disorders, and should not be used in patients with severe hypertension or severe coronary artery disease. Coexisting Conditions CLARINEX-D 24 HOUR Extended Release Tablets contain pseudoephedrine sulfate, a sympathomimetic amine, and therefore should be used with caution in patients with diabetes and hyperthyroidism. Also use with caution in patients with prostatic hypertrophy or increased intraocular pressure, as urinary retention or narrow-angle glaucoma may occur [see CONTRAINDICATIONS]. Co-Administration With Monoamine Oxidase (MAO) Inhibitors CLARINEX-D 24 HOUR Extended Release Tablets should not be used in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment as an increase in blood pressure or hypertensive crisis, may occur [see CONTRAINDICATIONS and DRUG INTERACTIONS]. Hypersensitivity Reactions Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of desloratadine a component of CLARINEX-D 24 HOUR Extended Release Tablets. If such a reaction occurs, therapy with CLARINEX-D 24 HOUR Extended Release Tablets should be stopped and alternative treatment should be considered [see ADVERSE REACTIONS Renal Impairment CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment [see CLINICAL PHARMACOLOGY]. Hepatic Impairment CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment [see CLINICAL PHARMACOLOGY]. Patient Counseling Information See FDA-approved patient labeling (PATIENT INFORMATION). Cardiovascular And Central Nervous System Effects Patients should be informed that pseudoephedrine, one of the active ingredients in CLARINEX-D 24 HOUR Extended Release Tablets may cause cardiovascular or central nervous system effects such as insomnia, dizziness, tremor, or arrhythmia. Dosing Patients should be advised not to increase the dose or dosing frequency of CLARINEX-D 24 HOUR Extended Release Tablets. Additional Antihistamines And/Or Decongestants Patients should be advised against the concurrent use of CLARINEX-D 24 HOUR Extended Release Tablets with other antihistamines and/or decongestants. Monoamine Oxidase (MAO) Inhibitors Patients should be informed that due to its pseudoephedrine component, they should not use CLARINEX-D 24 HOUR with a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor. Coexisting Conditions Patients with severe hypertension or severe coronary artery disease, narrow-angle glaucoma, or urinary retention should be advised not to use CLARINEX-D 24 HOUR Extended Release Tablets. Instructions For Use Patients should be instructed not to break, crush or chew the tablet. The tablet should be swallowed whole, and can be taken without regard to meals. For patent information: See PATIENT INFORMATION and/or www.merck.com/product/patent/home.html Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility There are no animal or laboratory studies on the combination product of desloratadine and pseudoephedrine sulfate to evaluate carcinogenesis, mutagenesis, or impairment of fertility. Carcinogenicity Studies The carcinogenic potential of desloratadine was assessed using a loratadine study in rats and a desloratadine study in mice. In a 2-year study in rats, loratadine was administered in the diet at doses up to 25 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 30 times the AUC in humans at the recommended daily oral dose). A significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg/day of loratadine and in males and females given 25 mg/kg/day of loratadine. The estimated desloratadine and desloratadine metabolite exposures in rats given 10 mg/kg of loratadine were approximately 7 times the AUC in humans at the recommended daily oral dose. The clinical significance of these findings during long-term use of desloratadine is not known. In a 2-year dietary study in mice, males and females given up to 16 mg/kg/day and 32 mg/kg/day desloratadine, respectively, did not show significant increases in the incidence of any tumors. The estimated desloratadine and desloratadine metabolite exposures in mice at these doses were 12 and 27 times, respectively, the AUC in humans at the recommended daily oral dose. Genotoxicity Studies In genotoxicity studies with desloratadine, there was no evidence of genotoxic potential in a reverse mutation assay (Salmonella/E. coli mammalian microsome bacterial mutagenicity assay) or in 2 assays for chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micronucleus assay). Impairment of Fertility There was no effect on female fertility in rats at desloratadine doses up to 24 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 130 times the AUC in humans at the recommended daily oral dose). A male specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and motility, and histopathologic testicular changes, occurred at an oral desloratadine dose of 12 mg/kg in rats (estimated desloratadine and desloratadine metabolite exposures were approximately 45 times the AUC in humans at the recommended daily oral dose). Desloratadine had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 8 times the AUC in humans at the recommended daily oral dose). Use In Specific Populations Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of desloratadine and pseudoephedrine in combination in pregnant women. Neither are there animal reproduction studies conducted with the combination of desloratadine and pseudoephedrine. Desloratadine was not teratogenic in rats or rabbits but affected implantation in rats. Because animal reproduction studies are not always predictive of human response, CLARINEX-D 24 HOUR Extended Release Tablets should be used during pregnancy only if clearly needed. Desloratadine was not teratogenic in rats or rabbits at approximately 210 and 230 times, respectively, the AUC in humans at the recommended daily oral dose. An increase in pre-implantation loss and a decreased number of implantations and fetuses were noted, however, in a separate study in female rats at approximately 120 times the AUC in humans at the recommended daily oral dose. Reduced body weight and slow righting reflex were reported in pups at approximately 50 times or greater than the AUC in humans at the recommended daily oral dose. Desloratadine had no effect on pup development at approximately 7 times the AUC in humans at the recommended daily oral dose. The AUCs in comparison referred to the desloratadine exposure in rabbits and the sum of desloratadine and its metabolites exposures in rats, respectively [see Nonclinical Toxicology]. Nursing Mothers Desloratadine and pseudoephedrine both pass into breast milk; therefore, a decision should be made whether to discontinue nursing or to discontinue CLARINEX-D 24 HOUR Extended Release Tablets, taking into account the benefit of the drug to the nursing mother and the possible risk to the child. Pediatric Use CLARINEX-D 24 HOUR Extended Release Tablets are not indicated for use in pediatric patients under 12 years of age. Geriatric Use The number of subjects (n=8) ≥ 65 years old treated with CLARINEX-D 24 HOUR Extended Release Tablets was too limited to make any formal statistical comparison regarding the efficacy or safety of this drug product in this age group, or to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences between the elderly and younger patients, although the elderly are more likely to have adverse reactions to sympathomimetic amines. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see CLINICAL PHARMACOLOGY]. Pseudoephedrine, desloratadine, and their metabolites are known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with renal impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor the patient for adverse events [see CLINICAL PHARMACOLOGY]. Renal Impairment No studies with CLARINEX-D 24 HOUR Extended Release Tablets were conducted in subjects with renal impairment. CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. Hepatic Impairment No studies with CLARINEX-D 24 HOUR Extended Release Tablets or pseudoephedrine have been conducted in subjects with hepatic impairment. CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. Gender No clinically significant gender-related differences were observed in the pharmacokinetic parameters of desloratadine, 3- hydroxydesloratadine or pseudoephedrine following administration of CLARINEX-D 24 HOUR Extended Release Tablets. Race No studies have been conducted to evaluate the effect of race on the pharmacokinetics of CLARINEX-D 24 HOUR Extended Release Tablets. Last reviewed on RxList: 5/5/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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